The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

A Phase III Randomized Trial of Three Antibiotic Regimens to Eradicate Helicobacter Pylori

Brief Summary

The purpose of this study is to compare the effectiveness of three different antibiotic regimens against Helicobacter pylori (H. pylori).

Detailed Description

Prevention of gastric cancer through eradication of H. pylori is one of the most promising strategies to reduce the global impact of cancer in the near term. Our long-term goal is to prevent gastric cancer by developing and validating an effective, simple, and low-cost approach to eradication of H. pylori. Our immediate goal, therefore, is to conduct a randomized study to compare the effectiveness of three different drug regimens for H. pylori infection. The three study arms are: Standard therapy - 14 day, 3-drug regimen of Lansoprazole, amoxicillin and clarithromycin (PACx14); Concomitant therapy - 5 day, 4-drug regimen of lansoprazole, amoxicillin, clarithromycin, metronidazole (PACMx5); Sequential therapy - 10 day, 4-drug regimen of lansoprazole, amoxicillin for 5 days, followed by lansoprazole, clarithromycin and metronidazole for 5 days (PAx5/PCMx5).

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

1859

Completion Date

July 2011

Primary Completion Date

July 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

positive Urea Breath Test documenting H. pylori infection

age 21 - 65 years

no known allergies to study drugs

only member of household participating in study

no known medical conditions (other than H. pylori) that would preclude or require antibiotic therapy

patients must be willing to discontinue alcohol use for 15 days (maximum duration of treatment plus one day)

patients must be willing to discontinue use of antacids for duration of study treatment

patients must not have used proton pump inhibitors (PPI) within 30 days of registration. Patients also must be willing to stop using non-study provided PPIs until the completion of the 6 week follow-up contact.

patients must not have been treated with antibiotics for H. pylori in the past and must not have taken any other antibiotics within 30 days of registration.

patients must be willing to return for 2 follow-up visits: 6 weeks after randomization following completion of treatment & 1 year after randomization

patients must be willing to allow submission of blood for assays of serum markers of bacterial virulence and host genetic susceptibility and environmental factors and provide consent for use of specimens.

Exclusion Criteria:

current use of anti-retroviral therapy for HIV or AIDS

diagnosed congestive hear failure

renal failure requiring dialysis

diagnosed hepatic failure resulting in hyperbilirubinemia

any current or prior malignancy except: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or Stage II cancer from which the patient has been disease free for 5 years

pregnancy or nursing mothers

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years to 65 Years (Adult)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects